Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
The text of this standard is sold by ISO and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| United States | Recognized | Second edition 2019 with Amendment 1 (2023) | - | Recognition number 14-595. Voluntary: a declaration of conformity to a recognized standard can be used in a submission. |
| European Union | Harmonized | EN ISO 11607-2:2020 with amendment A1:2023 (ISO 11607-2:2019) | - | Recognition number MDR entry 24; IVDR entry 13. Effective March 8, 2024. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: GB/T 19633.1-2024, ISO 11607-1, ASTM F1980, ASTM F88, ASTM F1929, ASTM F2096, ASTM D4169. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
| United Kingdom | Recognized | EN ISO 11607-2:2020 with amendment A1:2023 | - | Recognition number List row 95. Voluntary: a device that conforms to a designated standard is treated as complying with the related essential requirement unless there are reasonable grounds to suspect that it does not. |
| Canada | Recognized | Latest version (the list gives no edition or year) | - | When a new version is published, both the newest and the previous version stay recognized for 3 years from the date the newest version was published.. Voluntary: a manufacturer meets the standard, meets an equivalent or better standard, or gives other evidence of safety or effectiveness. A Declaration of Conformity is submitted when a recognized standard is used. |
| Australia | Recognized | ISO 11607-2:2019 | - | Compliance with the standard is treated as applying the matching parts of the conformity assessment procedures. It is an optional route. It applies to terminally sterilized devices. |